Kornimate/medical-research-clean huggingface dataset:
synbiotics in patients at risk for preterm birth

Conditions: Preterm Spontaneous Labor With Preterm Delivery; Preterm Birth; Microbial Colonization

Summary: prematurity remains the main cause of death and serious health problems in new-borns. besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). moreover, prematurity places an enormous economic burden on the society. aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated. previous preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. therefore, these women should be considered as 'high risk' for preterm birth. infections ascending from the vagina may be an important cause of preterm delivery in certain cases. some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. on the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation). synbiotics are a mixture containing probiotics and prebiotics. probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. it is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. in this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. the investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. the hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent must be obtained before any study assessment is performed; 2. 18 years of age or older; 3. singleton pregnancy; 4. pregnancy consultation between 8 and 10 weeks gestation. 5. at least one of the following risk factors for spontaneous preterm birth: * prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following pprom, preterm labor or cervical insufficiency * pprom ≤36 weeks in previous pregnancy * prior spontaneous second-trimester pregnancy loss, defined as pprom, preterm labor or cervical insufficiency with birth between 14 and 24 weeks. exclusion criteria: 1. patients who are already using pro-, pre- or synbiotics and not willing to stop 2. multiple pregnancy 3. need for primary (type 1) cerclage 4. inflammatory bowel disease 5. known congenital uterine anomaly 6. history of lletz conization

Keywords: preterm birth vaginal microbiome probiotics synbiotics
prediction of early recovery of liver function after ldlt in children: an ambispective cohort study

Conditions: Liver and Biliary Tract Disorders in Duration of Pregnancy; Other End-stage Liver Diseases in Children

Summary: the investigators included children with living donor liver transplantation (ldlt) from january 1, 2018 to july 31, 2022 as a retrospective cohort, and the group from august 1, 2022 to june 30, 2023 as a prospective cohort. the investigators collected the demographic and clinicopathological data of donors and recipients, and determined the risk factors of early postoperative delayed recovery of hepatic function (drhf) by univariate and multivariate logical regression analyses.


Eligibility criteria:
inclusion criteria: 1. children with the indication of ldlt \[cholestatic liver disease (such as ba), metabolic liver disease (such as wilson's disease and ornithine transcarbamylase deficiency), acute liver failure (such as drug induced), neoplastic disease (such as hepatoblastoma), vascular disease (such as cavernous transformation of portal vein and congenital absence of portal vein), re-transplantation and others\]; 2. the relatives of the children voluntarily donated part of the liver which met the requirements of ldlt. exclusion criteria: 1. recipients with contraindications of ldlt (such as coagulation dysfunction, acute infection, cardiopulmonary failure); 2. failure to complete ldlt due to various reasons (such as death during or within 3 days after operation); 3. recipients or donors with incomplete necessary data.
treatment of natural killer/t cell lymphoma-ⅲ/ⅳ

Conditions: Nasal and Nasal-type NK/T-cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of ddgp regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage ⅲ/ⅳ natural killer (nk)/t cell lymphoma.

patients with nk/t cell lymphoma usually have a bad prognosis. these patients cannot be treated successfully with the conventional chemotherapy of chop. the investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment ddgp (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage ⅲ/ⅳ nk/t cell lymphoma.

Eligibility criteria:
inclusion criteria: * age range 14-70 years old; ecog performance status 0-2; estimated survival time \> 3 months * histological confirmed nk/t cell lymphoma * none of chemotherapy or radiotherapy has been previously used * none of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/l, platelet ≥ 100×109/l, alt and ast ≤ 2×uln, serum bilirubin ≤ 1.5×uln, serum creatine ≤ 1.5×upper limitation of normal (uln), serum albumin ≥ 30g/l, serum plasminogen is normal (inclusion criteria of 1,3,6 groups ) * at least one measurable lesion * none of other serious diseases, cardiopulmonary function is normal * pregnancy test of women at reproductive age must be negative * patients could be followed up * none of other relative treatments including the traditional chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments. * volunteers who signed informed consent. exclusion criteria: * disagreement on blood sample collection * patients allergic of any of drug in this regimen or with metabolic disorder * pregnant or lactating women * serious medical illness likely to interfere with participation * serious infection * primitive or secondary tumors of central nervous system * chemotherapy or radiotherapy contraindication * the evidence of cns metastasis * history of peripheral nervous disorder or dysphrenia * patients participating in other clinical trials * patients taking other antitumor drugs * patients estimated to be unsuitable by investigator

Keywords: nk/t cell lymphoma chemotherapy clinical trial rr pfs os
adductor canal block versus periarticular bupivicaine injection in total knee arthroplasty

Conditions: Osteoarthritis

Summary: the objective of the study is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty. this randomized clinical trial will compare outcomes between adductor canal blocks, periarticular bupivacaine injections, and periarticular liposomal bupivacaine injections. results from this study will help determine the most appropriate perioperative pain management strategy for patients undergoing a total knee arthroplasty.

over 600,000 total knee arthroplasties (tkas) are performed each year in the united states, with expectations for greater than 4 million/year by the year 2030. since the onset of tkas in the 1960's, there have been developments that have improved both functionality and patient satisfaction. in the last decade, a focus has been made on multimodal pain management protocols, more rapid functional recovery, reduced length of hospital stay, and minimizing side effects of treatment while maintaining function and durability. the widespread use of regional anesthesia has led to improvements in pain control, more rapid functional recovery, and reduced length of stay. in recent years many surgeons have transitioned from femoral nerve blocks (proximal femoral nerve) to adductor canal blocks (distal femoral nerve) to maintain a sensory block for pain control, while minimizing any motor blockade that is typically seen in proximal femoral nerve blocks, which would hamper rehabilitation, and increase risk of falls. in addition to regional blocks, which are typically performed in the preoperative setting, some surgeons favor an intraoperative periarticular anesthetic injection (pai), typically with bupivacaine or the long acting form liposomal bupivacaine, either in conjunction with an adductor canal block, or independently. in theory, pai has the advantage of a comparable sensory nerve block as an adductor canal block, without the disadvantages and risks, which include prolonged quadriceps weakness, fall risk, and neurologic dysfunction. the purpose of this randomized control trial is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty.

Eligibility criteria:
inclusion criteria: - patients undergoing an unilateral primary total knee arthroplasty under the care of the two senior arthroplasty surgeons. exclusion criteria: - allergy to bupivicaine or liposomal bupivicaine.
mesenchymal stromal cells for acute graft versus host disease

Conditions: Acute GVH Disease

Summary: a randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy. it is hypothesised that mesenchymal stromal cell therapy will be superior

patients with newly diagnosed untreated acute graft versus host disease grades 2-4 will receive methylprednisolone 2.5mg/kg intravenously and randomised to receive or not receive allogeneic human mesenchymal stromal cells 2x10e6 intravenously on two occasions at weekly intervals

Eligibility criteria:
inclusion criteria: * grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation * age 18-55 years * must be receiving a calcineurin inhibitor exclusion criteria: * failure to sign informed consent * corticosteroid therapy for 72 hours or greater * ecog score equal to or greater than 3

Keywords: acute graft versus host disease bone marrow transplantation mesenchymal stromal cells
pain after root canal obturation with sealer containing or not 1% enoxolone

Conditions: Root Canal Obturation

Summary: this study aims to assess the efficacy of a zinc oxide eugenol sealer containing enoxolone, a non-steroidal anti inflammatory drug (nsaid) on the pain relief after endodontic treatment. the study design is a multicenter, doubled blinded randomized controlled trial. the comparator is the equivalent zinc oxide eugenol sealer without nsaid (allocation ratio is 1:1). the conventional endodontic treatment, using gutta percha and sealer, is done. patients assess their pain for 7 days after permanent root obturation.


Eligibility criteria:
inclusion criteria: * male or female aged from 18 to 70 years, * patient requiring root canal treatment on permanent mature teeth (single rooted teeth, premolar or molar), * informed consent signed, * patient with social protection. exclusion criteria: * root canal retreatment, * root canal treatment on an immature tooth, * calcified root canal assessed radiographically, * patient with one or more documented contraindication to endodontic treatment, * patient who takes regular analgesic or anti-inflammatory therapy for another pathology, * known allergy to nsaid or to one component of the sealer formula, * participation to another clinical trial at the same time, * known pregnancy or lactation, * patients with legal protection.
advanced renal cell carcinoma, with failure or unsuitable on prior interferon-alpha or interleukin-2 based therapy

Conditions: Carcinoma, Renal Cell

Summary: the primary objective of this prospective, observational, post-marketing study is to evaluate the patient characteristics, pre-treatment and treatment duration in renal cell carcinoma (rcc) patients who are candidates for systematic therapy and in whom a decision to treat with nexavar® has been made under real-life practice settings and approved reimbursement restriction in taiwan. therefore, the main objective of the study is to collect data on: prescription pattern: to determine the factors affecting compliance and duration of treatment with special attention given to education status, demography, disease details, pre-treatment, concomitant medication and other baseline data nexavar® treatment and efficacy data adverse events using common terminology criteria for adverse events (ctcae) version 4.0


Eligibility criteria:
inclusion criteria: * patients with diagnosis of advanced renal cell carcinoma (rcc) and decision taken by the investigator to prescribe nexavar® under taiwan reimbursement guideline * patients must have a life expectancy of at least 8 weeks exclusion criteria: * exclusion criteria must follow the approved local product information. * patients were lost to follow-up if no follow-up visit and no final assessment of nexavar® was documented.
an evaluation of a novel food product in adults residing in an area endemic for helminths

Conditions: Helminthiasis

Summary: the prevalence of intestinal helminths is worldwide. this study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.


Eligibility criteria:
inclusion criteria: * healthy male or female adults, age 18-45 years old inclusive on date of screening * showing presence of no or mild-moderate helminths exclusion criteria: * presence of heavy helminth load * pregnant or lactating * hepatosplenomegaly or clinically significant abnormal hemoglobin, lat or creatinine
open label assessment of long-term safety and utility

Conditions: Pain

Summary: the purpose of this study is to monitor the long-term analgesic effectiveness, safety, and utility of oxymorphone er for the relief of moderate to severe pain due to cancer.


Eligibility criteria:
inclusion criteria: * males or females aged \> 18 years with moderate to severe pain arising from cancer (histologically and/or clinically proven) who require chronic treatment with who step 3 analgesics. * women of child-bearing potential must be using an approved method of contraception (hormone contraception, iud, or double barrier method) and have a negative serum pregnancy test prior to entry into the study. * participated in study en3202-018; the patient must have been treated with study medication and completed the exit visit to be eligible. exclusion criteria: * experienced a serious, adverse experience during study en3202-018 that was possible or probably related to study medication. * withdrew from study en3202-018 due to an adverse experience possibly or probably related to study medication. * known idiosyncratic reaction or hypersensitivity to oxymorphone. * inability to take oral medication for 1 week. * patients with ileosomy, mechanical intestinal obstruction, partial or complete gastric outlet obstruction, parlayticileus, or other conditions that might contraindicate the use of, or impair the absorption of an oral controlled-release dosage form.
platelet rich plasma for patients with recurrent implantation failure

Conditions: Infertility

Summary: patients with recurrent implantation failure are among the most difficult patients to treat, with no proven standard treatment. platelet rich plasma stimulates cellular processes involved in endometrial regeneration, and in a small case series has shown efficacy for this patient population. we hope to conduct a randomized controlled pilot study to determine whether prp is indeed an effective treatment for recurrent implantation failure.

patients considered to have recurrent implantation failure will undergo randomization to receive intrauterine infusions of platelet rich plasma or a placebo of embryo culture media prior to their embryo transfer. all patients will undergo a blood draw to obtain 60ml of blood from which 0.5ml of platelet rich plasma will be obtained. those randomized to receive the platelet rich plasma will have platelet rich plasma placed into the uterine cavity at least 48 hours prior to the embryo transfer, while those randomized to receive placebo will have embryo culture media placed into the uterine cavity at the same point in time. those randomized to the placebo group will have the opportunity to be placed into the treatment group if no pregnancy was attained. transfer outcomes including implantation rate, pregnancy rate, and live birth rate, will be recorded.

Eligibility criteria:
inclusion criteria: * all women who have undergone 3 or more embryo (blastocyst stage) transfers without establishing a clinical pregnancy or 2 or more euploid embryo transfers without establishing a clinical pregnancy, aged 18 - 45, with a normal uterine cavity established within 12 months by hysteroscopy or saline infusion sonogram, planning in vitro fertilization with an embryo transfer at stanford fertility and reproductive health. the planned transfer must consist of any of the following: a pgs proven euploid embryo, a good quality blastocyst from a patient younger than 37, or a donor oocyte blastocyst. exclusion criteria: * abnormal uterine cavity, planning in vitro fertilization with use of a gestational carrier. patients enrolled in other experimental interventions for rif will be excluded. patients with only poor quality or cleavage stage embryos.

Keywords: recurrent implantation failure
comparison of the fgm profiles in patients of type 2 diabetes treated with sitagliptin and acarbose

Conditions: Type 2 Diabetes

Summary: the aim of the study is to compare the fgm glycemic profiles in patients with type 2 diabetes mellitus treated with sitagliptin and acarbose.

in this study, 60 patients with type 2 diabetes were randomly divided into group a or group b after stable glucose control. flash glucose mornitoring(fgm) will be used in patients with two groups. patients in group a were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks. fgm was used to monitor glycemic variations during the whole four weeks. the opposite therapy was true for patients in group b.

Eligibility criteria:
inclusion criteria: 1. participate voluntarily and sign the subject informed consent before the test. 2. patients with type 2 diabetes, aged 18-75 years, meeting the diagnostic criteria of who1999, have not been treated with any hypoglycemic drugs. 3. no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome. 4. subjects are able and willing to undergo fgm examination, diet and exercise regularly. exclusion criteria: 1. patients allergic to insulin. 2. impaired liver and renal function, alt 2.5 times higher than the upper limit of normal value;serum creatinine was 1.3 times higher than the upper limit of normal. 3. a history of drug abuse and alcohol dependence within the past 5 years. 4. systemic hormone therapy was used in recent 3 months. 5. patients with poor compliance and irregular diet and exercise. 6. patients with infection and stress within four weeks. 7. patients who cannot tolerate flash glucose mornitoring(fgm). 8. patients who are pregnant, nursing or preparing to become pregnant. 9. any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.
trial to determine the maximum tolerated dose (mtd) based on safety and tolerability, of org 26576 in participants with major depressive disorder (174001/p05704/mk-8777-001)

Conditions: Depression

Summary: trial to determine the maximum tolerated dose (mtd) based on safety and tolerability of mk-8777 (org 26576, sch 900777) in participants with major depressive disorder.

this is a randomized, placebo-controlled, safety and tolerability study examining mk-8777 in participants with major depressive disorder. in part i of the trial, four different cohorts of six participants each will receive multiple rising doses of mk-8777 (ranging from 100 mg twice a day \[bid\] to 300 mg bid) or placebo for up to 16 days. in part 2, a new cohort of participants will be randomly assigned to receive 100 mg bid of mk-8777, 400 mg bid of mk-8777, or placebo. following titration (3 days per step), participants will be maintained on the assigned bid dose until day 27, followed by one day of once a day (qd) dosing, for a total of 28 days. there were 11 treatment arms in total for part 1 and part 2 (see interventions).

Eligibility criteria:
inclusion criteria: * female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential; * be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the quick inventory of depression symptomatology - clinician rated (qids-c); * be anti-depressant naïve; * be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge; * smokes less than or equal to 10 cigarettes or equivalent daily. exclusion criteria: * has any current and primary axis i disorder other than major depressive disorder; * has any history of bipolar i or ii disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder; * the duration of the current depressive episode is longer than 2 years at screening; * has any history of a significant suicide attempt, or poses a current risk of attempting suicide; * is known to be human immunodeficiency virus (hiv) positive, or positive for hepatitis b surface antigen or hepatitis a antibodies or hepatitis c total antibodies; * has any clinically significant concurrent endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, malignancy, or any other concurrent medical condition, or has any history of diabetes mellitus; * donation of blood within 60 days prior to the anticipated first dose of trial medication.

Keywords: randomized placebo controlled maximum tolerated dose